MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION 2-PRONG GLENOSPHERE INSERTER/IMPACTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110028879
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the impactor fractured.No complications, injuries, or surgical interventions were reported.Attempts have been made, and no further information has been provided.
Event or Problem Description
It was further reported the instrument was bent to the point of not being usable in future surgeries.The device failed at the time of glenosphere impaction.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.The surgery was completed with an alternate device.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a3; b4; b5; d2; g1; g3; g6; h1; h2; h6 further information received confirms that the device did not fracture but bent to the point of the instrument becoming unusable.Further, the event did not contribute to a serious injury; therefore, this would not be considered a reportable event.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g4; g6; h1; h2; h3; h6.The reported event is confirmed through product return.Visual examination of the returned product identified signs of repeated use (scratches nicks and dings).Threaded shaft is bent.Black end cap is chipped (not all returned).Strike plate has numerous impact marks.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.-1 was submitted in error and should be disregarded.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE INSTRUMENTATION 2-PRONG GLENOSPHERE INSERTER/IMPACTOR
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22284874
• Report Number: 0001825034-2025-01780
• Device Sequence Number: 15672476
• Product Code: PHX
• UDI-Device Identifier: 00880304731394
• UDI-Public: (01)00880304731394(11)181218(10)907960
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110028879
• Device Lot Number: 907960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 09/26/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/06/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female